Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD (RESOLVE-CKD)
2026. június 17. frissítette: Jing Chen, University of Texas Southwestern Medical Center
Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD: A Pilot Randomized Open-Label Trial (RESOLVE-CKD Trial)
The overall objective of this pilot randomized clinical trial is to determine whether low-dose Colchicine (LoDoCo) improves vascular disease including vascular calcification, peripheral arterial disease (PAD), and chronic kidney disease-mineral and bone disorder (CKD-MBD) biomarkers in patients with chronic kidney disease (CKD) stage 3 over a 12-month intervention period, compared with usual care.
Successful completion of this study will generate critical preliminary data to support a larger clinical trial aimed at evaluating inflammation-targeted therapies to mitigate CKD-MBD, including vascular calcification and related PAD, as well as osteoporosis, ultimately reducing cardiovascular events and mortality in patients with CKD. Additionally, this work has the potential to redefine the diagnostic framework for CKD-MBD.
A tanulmány áttekintése
Állapot
Még nincs toborzás
Körülmények
Beavatkozás / kezelés
Részletes leírás
The investigators will conduct a randomized, open-label, outcome blinded mechanistic clinical trial in 60 adults with stage 3 chronic kidney disease (CKD) who have hypertension, diabetes, dyslipidemia, or established atherosclerotic cardiovascular disease (ASCVD).
The investigators will evaluate whether low-dose Colchicine (LoDoCo) improves coronary artery calcification (CAC) and mineral and bone disorders (MBD) over 12 months in patients with CKD, eGFR ≥30 to 59 mL/min/1.73 m², and urine albumin-to-creatinine ratio (uACR) ≥200 mg/g. Sixty participants with CKD stage 3 and increased risk of, or established, ASCVD will be randomized 1:1 to receive LoDoCo plus usual care or usual care alone. Primary outcomes include changes in Agaston scores assessed by cardiac computed tomography (CCT) from baseline to 12 months, second outcomes include changes in the individual biomarkers of MBD and vascular calcification (VC) from baseline and 12 months. Exploratory outcomes include changes in uACR, estimated glomerular filtration rate (eGFR), ankle-brachial index (ABI), and toe-brachial index (TBI). Safety and tolerability will also be evaluated. Participants will be followed at baseline, 6 months, and 12 months for data collection, with an in-person visit at 1 month for safety evaluation. Additional safety assessments for side effects may be conducted by phone at any time.
Tanulmány típusa
Beavatkozó
Beiratkozás (Becsült)
60
Fázis
- 2. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi kapcsolat
- Név: Paola Lanza, MD
- Telefonszám: 469-852-9550
- E-mail: paola.lanza@UTSouthwestern.edu
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Alexandra R Hartman
- Telefonszám: 614-420-1186
- E-mail: RESOLVE-CKD@UTSouthwestern.edu
Tanulmányi helyek
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-
Texas
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Dallas, Texas, Egyesült Államok, 75390
- University of Texas Southwestern Medical Center
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Kutatásvezető:
- Jing Chen, MD
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Kapcsolatba lépni:
- Paola Lanza, MD
- Telefonszám: 469-852-9550
- E-mail: paola.lanza@UTSouthwestern.edu
-
Kapcsolatba lépni:
- Alexandra R Hartman
- Telefonszám: 214-645-8294
- E-mail: alexandra.hartman@UTSouthwestern.edu
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-
Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Nem
Leírás
Inclusion Criteria:
- Men and women aged 18-<70 years of all race/ethnicity groups
- CKD stage 3 (estimated glomerular filtration rate (eGFR) >30 to 59 ml/min/1.73m2)
- Urine albumin-to-creatinine ratio (uACR) ≥ 200 mg/g
- Cardiac artery calcification (CAC) Agatston score ≥30
- Hypertension, diabetes, dyslipidemia, or established atherosclerotic cardiovascular disease (ASCVD) (coronary artery disease (CAD), ischemic stroke, and peripheral artery disease), defined by self-report, ICD-10 codes, or the use of medications for these conditions.
- Ability to provide informed consent.
Exclusion Criteria:
- Current Colchicine therapy
- Hepatic disease
- Any clinically active diagnosed infection requiring systemic antimicrobial therapy, positive microbiologic evidence of infection, or infection-related hospitalization within 30 days prior to study enrollment.
- Immunosuppression
- Current use of chemotherapy drugs or active cancer
- Pregnancy/breastfeeding
- Hospitalized within the past 6 months
- Allergic/intolerance to colchicine
- Use of P-glycoprotein (p-gp) inhibitor (such as Verapamil, Quinidine, Amiodarone, Ritonavir, Lopinavir/ritonavir, Saquinavir, Nelfinavir)
- Use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (such as Ketoconazole, Itraconazole, Posaconazole, Voriconazole, Clarithromycin, Erythromycin)
- Human immunodeficiency virus (HIV) infection
- Gout attack ≥ 1 time per year
- Severe anemia (hemoglobin < 8 g/dl for women and < 9 g/dl for men)
- eGFR <30 ml/min/1.73m2
- uACR <200 mg/g
- White blood cell count (WBC) <3.0 x109/L
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x Upper Limit of Normal (ULN)
- Total bilirubin >2 x ULN
- Glucose >300mg/dl
- Uses nicotine products or other recreational drugs
- Unable to read or speak English
- Participant in other conflict clinical trial,
- Unable to complete the study measurements
- Unable to undergo to computed tomography (CT) or dual-energy X-ray absorptiometry (DXA) scans
- Unsafe to participate in this study per investigator's judgement.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Aktív összehasonlító: Low-Dose Colchicine (LoDoCo)
Participants will receive low-dose Colchicine (LoDoCo) in addition to usual care.
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Intervention group will receive LoDoCo (Colchicine 0.5mg), oral, once daily.
Más nevek:
Participants will receive usual care according to standard clinical practice and treating physician discretion.
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Aktív összehasonlító: Usual Care
Participants will receive usual care alone.
|
Participants will receive usual care according to standard clinical practice and treating physician discretion.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in Coronary Artery Calcification Agatston Scores
Időkeret: Baseline, 12 months
|
Agatston scores (Agatston units) will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.
Coronary artery calcification will be quantified using the Coronary Artery Calcium (CAC) Agatston Score.
Scores range from 0 Agatston units (no detectable coronary calcification), 1-99 Agatston units (mild calcification), 100-399 Agatston units (moderate calcification), and ≥400 Agatston units (severe calcification, high atherosclerotic burden).
Higher scores indicate greater coronary artery calcification and are associated with worse outcomes.
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Baseline, 12 months
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in Coronary Artery Calcification Volume Scores
Időkeret: Baseline, 12 months
|
Change in Coronary Artery Calcification volume (mm3) will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.
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Baseline, 12 months
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Change in Cardiac Artery Calcification Mass Scores
Időkeret: Baseline, 12 months
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Change in Cardiac Artery Calcification Mass (mg) score will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.
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Baseline, 12 months
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Change in Serum Klotho Levels
Időkeret: Baseline, 6 months, 12 months
|
Circulating klotho levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
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Change in Fetuin A Levels
Időkeret: Baseline, 6 months, 12 months
|
Circulating fetuin A levels (ng/mL) will be measured using standard clinical laboratory assays
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Baseline, 6 months, 12 months
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Change in Serum Phosphate levels
Időkeret: Baseline, 6 months, 12 months
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Circulating serum phosphate levels (mg/dL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Serum Calcium Levels
Időkeret: Baseline, 6 months, 12 months
|
Circulating serum calcium levels (mg/dL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Parathyroid Hormone (PTH) levels
Időkeret: Baseline, 6 months, 12 months
|
Circulating PTH levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in C-terminal Fibroblast Growth Factor 23 (FGF23) Levels
Időkeret: Baseline, 6 months, 12 months
|
Circulating C-terminal FGF23 levels (RU/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Fibroblast Growth Factor 23 (FGF23) Levels
Időkeret: Baseline, 6 months, 12 months
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Circulating FGF23 levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Bone-Specific Alkaline Phosphatase (BSAP) Levels
Időkeret: Baseline, 6 months, 12 months
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Circulating serum BSAP levels (ug/L) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in C-terminal Telopeptide of Type I Collagen (CTX)
Időkeret: Baseline, 6 months, 12 months
|
Circulating CTX levels (ng/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
|
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Change in Tartrate-Resistant Acid Phosphatase 5b (TRAP-5b) Levels
Időkeret: Baseline, 6 months, 12 months
|
Circulating TRAP-5b levels (U/L) will be measured using standard clinical laboratory assays
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Baseline, 6 months, 12 months
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Change in Sclerostin Levels
Időkeret: Baseline, 6 months, 12 months
|
Circulating sclerostin levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Lumbar Spine Bone Mineral Density (BMD)
Időkeret: Baseline, 12 months
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BMD at the lumbar spine (g/cm2) will be measured by Hologic or GE Lunar DXA system following standard manufacturer protocols.
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Baseline, 12 months
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Change in Hip Bone Mineral Density (BMD)
Időkeret: Baseline, 12 months
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BMD at the hip (g/cm2) will be measured by Hologic or GE Lunar DXA system following standard manufacturer protocols.
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Baseline, 12 months
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Change in Radius Bone Mineral Density (BMD)
Időkeret: Baseline, 12 months
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BMD at the radius (g/cm2) will be measured by Hologic or GE Lunar DXA system following standard man
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Baseline, 12 months
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Change in Interleukin-6 (IL-6) Levels
Időkeret: Baseline, 6 months, 12 months
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Circulating IL-6 levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Soluble Tumor Necrosis Factor Receptor 1 (sTNFR1) Levels
Időkeret: Baseline, 6 months, 12 months
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Circulating sTNFR1 levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Interleukin-17 (IL-17) Levels
Időkeret: Baseline, 6 months, 12 months
|
Circulating IL-17 levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Intact N-Terminal Propeptide of Type I Procollagen (P1NP) Levels
Időkeret: Baseline, 6 months, 12 months
|
Circulating P1NP levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Exploratory: Change in Urine Albumin-to-Creatine Ratio (uACR)
Időkeret: Baseline, 6 months, 12 months
|
Circulating urinary albumin and creatine levels (mg/dL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
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Exploratory: Change in Estimated Glomerular Filtration Rate (eGFR)
Időkeret: Baseline, 6 months, 12 months
|
eGFR values (mL/min/1.73m2)
will be calculated using the NKF-ASN CKD-Epi refit formula.
|
Baseline, 6 months, 12 months
|
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Exploratory: Change in Ankle-Brachial Index (ABI)
Időkeret: Baseline, 6 months, 12 months
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ABI will be measured using semi-automated validated device (simpleABI-600CL).
ABI values range from ≤0.90 (Peripheral artery disease), 0.91-0.99
(borderline), 1.00-1.40
(normal).
ABI values >1.40 indicate non-compressible arteries, suggestive of arterial stiffness or medial calcification.
Both ABI values ≤0.90 and >1.40 are associated with worse outcomes.
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Baseline, 6 months, 12 months
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Exploratory: Change in Toe-Brachial Index (TBI)
Időkeret: Baseline, 6 months, 12 months
|
TBI will be measured using semi-automated validated device (simpleABI-600CL).
TBI values range from ≥0.70 (normal), 0.64-0.69
(borderline), and <0.40-0.50
(severe distal arterial disease/critical ischemia range).
TBI values <0.70 is a commonly used threshold suggestive of peripheral artery disease.
Lower TBI values are associated with worse outcomes.
|
Baseline, 6 months, 12 months
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Nyomozók
- Kutatásvezető: Jing Chen, MD, University of Texas
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
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- Geng S, Kuang Z, Peissig PL, Page D, Maursetter L, Hansen KE. Parathyroid hormone independently predicts fracture, vascular events, and death in patients with stage 3 and 4 chronic kidney disease. Osteoporos Int. 2019 Oct;30(10):2019-2025. doi: 10.1007/s00198-019-05033-3. Epub 2019 May 31.
- Isakova T, Cai X, Lee J, Xie D, Wang X, Mehta R, Allen NB, Scialla JJ, Pencina MJ, Anderson AH, Talierco J, Chen J, Fischer MJ, Steigerwalt SP, Leonard MB, Hsu CY, de Boer IH, Kusek JW, Feldman HI, Wolf M; Chronic Renal Insufficiency Cohort (CRIC) Study Investigators. Longitudinal FGF23 Trajectories and Mortality in Patients with CKD. J Am Soc Nephrol. 2018 Feb;29(2):579-590. doi: 10.1681/ASN.2017070772. Epub 2017 Nov 22.
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Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
2026. július 1.
Elsődleges befejezés (Becsült)
2027. december 1.
A tanulmány befejezése (Becsült)
2027. december 31.
Tanulmányi regisztráció dátumai
Először benyújtva
2026. június 11.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2026. június 11.
Első közzététel (Tényleges)
2026. június 17.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2026. június 22.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. június 17.
Utolsó ellenőrzés
2026. június 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
- Urogenitális betegségek
- Endokrin rendszer betegségei
- Csontbetegségek
- Mozgásszervi betegségek
- Érrendszeri betegségek
- Szív-és érrendszeri betegségek
- Patológiás folyamatok
- Táplálkozási zavarok
- Férfi urogenitális betegségek
- Vesebetegségek
- Urológiai betegségek
- Női urogenitális betegségek
- Női urogenitális betegségek és terhességi szövődmények
- Krónikus betegség
- Betegség tulajdonságai
- Anyagcsere-betegségek
- Glükóz anyagcserezavarok
- Veseelégtelenség
- Csontbetegségek, anyagcsere
- Mellékpajzsmirigy betegségek
- Lipid anyagcsere zavarok
- Érelmeszesedés
- Artériás elzáródásos betegségek
- Avitaminózis
- Hiánybetegségek
- Alultápláltság
- Angolkór
- Kalcium-anyagcsere zavarok
- D-vitamin hiány
- Calcinosis
- Hyperparathyreosis, másodlagos
- Hyperparathyreosis
- Kóros állapotok, jelek és tünetek
- Táplálkozási és anyagcsere-betegségek
- Magas vérnyomás
- Diabetes mellitus
- Veseelégtelenség, krónikus
- Dislipidémiák
- Érelmeszesedés
- Vaszkuláris meszesedés
- Krónikus vesebetegség – ásványianyag- és csontbetegség
- Heterociklusos vegyületek
- Alkaloidok
- Kolchicin
Egyéb vizsgálati azonosító számok
- STU20260896
- 99077 (Egyéb azonosító: UT Southwestern Medical Center)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IGEN
IPD terv leírása
IRB approval is required before sharing IPD.
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
- NEDV
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Igen
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Nem
az Egyesült Államokban gyártott és onnan exportált termék
Igen
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .